Biosimilar mAbs in Europe move one step closer to reality

Having issued a concept paper on the topic in October 2009, the European Medicines Agency has now confirmed that it is to publish its highly anticipated biosimilar monoclonal antibody development guidance in November 2010. The guidelines will likely have a huge impact on the market, serving to clarify the details of biosimilar development and a pathway for their approval in Europe.

The European Medicines Agency (EMA) announcement comes exactly one year after it published a concept paper on the development of biosimilar monoclonal antibodies (mAbs). The draft guidance will be open for consultation for three to six months, and is likely to be adopted during Q3 2011.

As with other class-level biosimilar development guidelines (of which there are six), the EMA's biosimilar mAb guidance is likely to focus on quality, non-clinical, clinical and post-marketing surveillance requirements. However, it is the clinical trial requirements for biosimilar mAbs in which stakeholders will be most interested.

In an interview on October 1, 2010, the EMA's executive director, Thomas Lonngren, confirmed that clinical trials would be needed to prove that a biosimilar mAb was similar to the originator mAb. However, he did not give any indication of how extensive these clinical trials would need to be, and if extrapolation of indications (i.e. the biosimilar receiving approval for an indication without having to conduct any clinical trials in that indication) would be permitted for biosimilar mAbs. If this were permitted, it would make it easier to compete in the biosimilar mAbs space, as those companies unable to invest in extensive clinical development programs would be able to compete.

However, recent events in the EU biosimilar mAbs space could suggest that extrapolation will not be permitted. Israeli generics firm Teva has initiated EU-based early stage clinical trials of TL011, a biosimilar version of rituximab (Rituxan/MabThera; Roche) in both severe rheumatoid arthritis and CD20-positive diffuse b-cell non-Hodgkin's lymphoma. This would suggest that Teva believes extrapolation of indications will not be permitted.

In addition to Teva, this announcement is likely to be of significant interest to many other stakeholders in the biopharmaceutical sector, including branded biotech, biosimilar and pharmaceutical companies. Indeed, the size of the prize is huge. Datamonitor analysis has shown that in 2009 the global mAb market was worth an estimated $36 billion. Between 2009 and 2015, the market is forecast to expand to $63 billion.

It would seem that branded companies such as Roche, Abbott and Johnson & Johnson have much to lose, while companies such as Teva have much to gain. Outside of Europe, there are a number of additional biosimilar mAb developers with a vested interest in this announcement. Companies such as Hospira (US), Biocon (India), Celltrion (Korea) and 3SBio (China) are all reportedly pursuing biosimilar mAb development opportunities.

Datamonitor considers the publication of these biosimilar mAb guidelines as a pivotal event in the evolution of the biosimilars market. By clarifying what will be required to develop and obtain approval for a biosimilar mAb, many of the myths and rumors surrounding this issue will disappear, and bring biosimilar mAbs one step closer to reality.